Latest & greatest articles for sofosbuvir

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Top results for sofosbuvir

1. Daclatasvir and sofosbuvir treatment of decompensated liver disease or post‐liver transplant hepatitis C virus recurrence in patients with advanced liver disease/cirrhosis in a real‐world cohort Full Text available with Trip Pro

Daclatasvir and sofosbuvir treatment of decompensated liver disease or post‐liver transplant hepatitis C virus recurrence in patients with advanced liver disease/cirrhosis in a real‐world cohort We report the findings of an early access program providing treatment for chronic hepatitis C virus infection (any genotype) with daclatasvir and sofosbuvir with/without ribavirin to patients with Child-Pugh class C cirrhosis or prior liver transplant recipients with recurrent hepatitis C virus (...) infection and advanced fibrosis/cirrhosis. Patients had <12-month life expectancies per the local investigator. Patients received daclatasvir 60 mg and sofosbuvir 400 mg once daily, with/without ribavirin, for 24 weeks. Sustained virologic response (SVR) at posttreatment week 12 (SVR12) was measured. Assessments adhered to local standards. One patient (prior Child-Pugh class C who improved to class B) enrolled by exemption was included in the overall data but not the class C cohort efficacy/safety data

2018 Hepatology communications

2. Sofosbuvir?velpatasvir for treating chronic hepatitis C

Sofosbuvir?velpatasvir for treating chronic hepatitis C Sofosbuvir–v Sofosbuvir–velpatasvir for treating elpatasvir for treating chronic hepatitis C chronic hepatitis C T echnology appraisal guidance Published: 25 January 2017 nice.org.uk/guidance/ta430 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance represent the view of NICE, arrived (...) . Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Sofosbuvir–velpatasvir for treating chronic hepatitis C (TA430) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 31Contents Contents 1 Recommendations 4 2 The technology 6 3 Evidence 7 4 Committee

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

3. Daclatasvir and sofosbuvir (Sovaldi) with and without ribavirin for chronic hepatitis C infection

Daclatasvir and sofosbuvir (Sovaldi) with and without ribavirin for chronic hepatitis C infection Daclatasvir and sofosbuvir (Sovaldi) with and without ribavirin for chronic hepatitis C infection Daclatasvir and sofosbuvir (Sovaldi) with and without ribavirin for chronic hepatitis C infection NIHR HSC Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database (...) . Citation NIHR HSC. Daclatasvir and sofosbuvir (Sovaldi) with and without ribavirin for chronic hepatitis C infection. Birmingham: NIHR Horizon Scanning Centre (NIHR HSC). Horizon Scanning Review. 2014 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Antiviral Agents; Hepatitis C, Chronics; Uridine Monophosphate Language Published English Country of organisation England English summary An English language summary is available. Address for correspondence The NIHR Horizon

2014 Health Technology Assessment (HTA) Database.

4. Ledipasvir/Sofosbuvir

Ledipasvir/Sofosbuvir CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205834Orig1s000 MEDICAL REVIEW(S) MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DIVISION OF ANTIVIRAL PRODUCTS DATE: September 25, 2014 TO: NDA 205834 SDN 32, received August 7, 2014 FROM: Medical Officer, Division of Antiviral Products SUBJECT: GS-US-337-0115 and NIAID-13-I-0159 Summary Interim Safety Data GS-US-337 (...) -0115, A Phase 3, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects with Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co Infections NIAID-13-I-0159, An Open Label Trial to Assess Safety, Tolerability, and Efficacy of the Fixed Dose Combination of GS-5885 and GS-7977 in HCV Genotype 1 Subjects Coinfected with HIV Summary interim safety data are available from

2014 FDA - Drug Approval Package

5. Sofosbuvir?velpatasvir?voxilaprevir for treating chronic hepatitis C

Sofosbuvir?velpatasvir?voxilaprevir for treating chronic hepatitis C Sofosbuvir–v Sofosbuvir–velpatasvir–v elpatasvir–vo oxilapre xilaprevir for vir for treating chronic hepatitis C treating chronic hepatitis C T echnology appraisal guidance Published: 21 February 2018 nice.org.uk/guidance/ta507 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations (...) and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Sofosbuvir–velpatasvir–voxilaprevir for treating chronic hepatitis C (TA507) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 17Contents Contents 1 Recommendations

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

6. Sofosbuvir (hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V

Sofosbuvir (hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Sofosbuvir (chronische Hepatitis C bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 January 2018). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A17-55 Sofosbuvir (chronic hepatitis C in adolescents) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-55 Version 1.0 Sofosbuvir (chronic hepatitis C in adolescents) 11 January 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sofosbuvir (chronic hepatitis C in adolescents) – Benefit assessment according to §35a Social Code Book V

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

7. Sofosbuvir Use in the Setting of End-stage Renal Disease: A Single Center Experience Full Text available with Trip Pro

Sofosbuvir Use in the Setting of End-stage Renal Disease: A Single Center Experience Background and Aims: Patients with chronic hepatitis C (CHC) and end-stage renal disease (ESRD) who are dialysis-dependent form a unique group, in which safety, tolerability and efficacy of sofosbuvir (SOF)-based direct-acting antivirals (DAAs) need further evaluation. Methods: We performed a retrospective analysis of 14 patients with CHC and ESRD on dialysis who received 15 courses of SOF-based therapy. We

2017 Journal of clinical and translational hepatology

8. Ledipasvir/sofosbuvir (Harvoni®)

Ledipasvir/sofosbuvir (Harvoni®) Ledipasvir/sofosbuvir (Harvoni®) Ledipasvir/sofosbuvir (Harvoni®) All Wales Medicines Strategy Group (AWMSG) Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation All Wales Medicines Strategy Group (AWMSG). Ledipasvir/sofosbuvir (Harvoni®) Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales (...) Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 1887. 2015 Authors' conclusions Ledipasvir/sofosbuvir (Harvoni®) is recommended as an option for restricted use within NHS Wales for the treatment of chronic hepatitis C in adults with hepatitis C virus genotype 1 and 4 without cirrhosis or with compensated cirrhosis for up to 12 weeks. Ledipasvir/sofosbuvir (Harvoni®) is not recommended for use within NHS Wales outside of this subpopulation/these circumstances. Key factor

2015 Health Technology Assessment (HTA) Database.

9. Ledispavir / sofosbuvir (Harvoni) - treatment of chronic hepatitis C (CHC) in adolescents

Ledispavir / sofosbuvir (Harvoni) - treatment of chronic hepatitis C (CHC) in adolescents Abbreviated Submission ledipasvir/sofosbuvir 90mg/400mg film-coated tablet (Harvoni ® ) SMC No 1343/18 Gilead Sciences 4 May 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following an abbreviated submission (...) ledipasvir/sofosbuvir (Harvoni ® ) is accepted for restricted use within NHS Scotland. Indication under review: treatment of chronic hepatitis C (CHC) in adolescents aged 12 to <18 years. SMC restriction: genotype 1 and 4 CHC only. SMC has previously accepted ledipasvir/sofosbuvir for use in adults with genotype 1 and 4 CHC. Advice context: No part of this advice may be used without the whole of the advice being quoted in full. This advice represents the view of the Scottish Medicines Consortium

2018 Scottish Medicines Consortium

10. Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant

Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more (...) . Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant (STOP-CO) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02533934 Recruitment Status : Active, not recruiting First Posted : August 27, 2015 Last Update Posted : December 19, 2018 Sponsor: University of California, San

2015 Clinical Trials

11. Adverse effects of pseudoephedrine and sofosbuvir

Adverse effects of pseudoephedrine and sofosbuvir Prescrire IN ENGLISH - Spotlight ''In the January issue of Prescrire International: adverse effects of pseudoephedrine and sofosbuvir'', 1 January 2017 {1} {1} {1} | | > > > In the January issue of Prescrire International: adverse effects of pseudoephedrine and sofosbuvir Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |   |  (...)  |  Spotlight In the January issue of Prescrire International: adverse effects of pseudoephedrine and sofosbuvir FREE DOWNLOAD In the "Adverse Effects" section of this month's issue, ischaemic colitis with the decongestant pseudoephedrine, and a risk of pulmonary arterial hypertension with the hepatitis C drug sofosbuvir. Full text available for free download. Pseudoephedrine: ischaemic colitis Sympathomimetic vasoconstrictors can provoke neurological and cardiovascular adverse effects

2017 Prescrire

12. Clinical review report. Sofosbuvir (Sovaldi ? Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection

Clinical review report. Sofosbuvir (Sovaldi ? Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection Clinical review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection Clinical review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation (...) of the quality of this assessment has been made for the HTA database. Citation CADTH. Clinical review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDR Clinical Review Report; SR0356. 2014 Authors' conclusions There were four RCTs included in this review that enrolled patients with genotypes 2 or 3 (FISSION, FUSION, POSITRON, and VALENCE), but only one single-arm study (NEUTRINO

2014 Health Technology Assessment (HTA) Database.

13. Sovaldi - sofosbuvir

Sovaldi - sofosbuvir 21 November 2013 EMA/CHMP/688774/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Sovaldi International non-proprietary name: sofosbuvir Procedure No. EMEA/H/C/002798/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E (...) /2013 Page 5/100 SmPC summary of product characteristics SOF sofosbuvir (GS-7977; formerly PSI-7977) SVR, SVRxx sustained virologic response, sustained virologic response at “xx” weeks following completion of all treatment TDF tenofovir disoproxil fumarate TND target not detected TTC threshold of toxicological concern ULN upper limit of the normal range US UV United States ultra-violet Assessment report EMA/CHMP/688774/2013 Page 6/100 1. Background information on the procedure 1.1. Submission

2014 European Medicines Agency - EPARs

14. Sofosbuvir/Velpatasvir for 12 Weeks in Hepatitis C Virus-Infected Patients with End-Stage Renal Disease Undergoing Dialysis. Full Text available with Trip Pro

Sofosbuvir/Velpatasvir for 12 Weeks in Hepatitis C Virus-Infected Patients with End-Stage Renal Disease Undergoing Dialysis. Although off-label use of sofosbuvir-containing regimens occurs regularly in patients with hepatitis C virus (HCV) infection undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD), these regimens are not licensed for this indication, and there is an absence of dosing recommendations in this population. This study evaluated the safety (...) and efficacy of sofosbuvir/velpatasvir in patients with HCV infection with ESRD undergoing dialysis.In this phase 2, single-arm study, 59 patients with genotype 1-6 HCV infection with ESRD undergoing hemodialysis or peritoneal dialysis received open-label sofosbuvir/velpatasvir (400 mg/100 mg) once daily for 12 weeks. Patients were HCV treatment naive or treatment experienced without cirrhosis or with compensated cirrhosis. Patients previously treated with any HCV NS5A inhibitor were not eligible

2019 Journal of Hepatology

15. Ledipasvir-Sofosbuvir for 12 Weeks in Children 3 to &lt;6 Years Old With Chronic Hepatitis C. Full Text available with Trip Pro

Ledipasvir-Sofosbuvir for 12 Weeks in Children 3 to <6 Years Old With Chronic Hepatitis C. For children under 12 years of age who have chronic hepatitis C virus (HCV) infection, there are currently no approved treatments with direct-acting antiviral agents. We therefore evaluated the safety and efficacy of ledipasvir-sofosbuvir in HCV-infected children aged 3 to <6 years old. In an open-label study, patients 3 to <6 years old chronically infected with HCV genotype 1 (n=33) or 4 (n=1 (...) ) received weight-based doses of combined ledipasvir-sofosbuvir as granules (33.75 mg/150 mg for weights <17 kg or 45 mg/200 mg for weights ≥17 kg) for 12 weeks. The primary endpoint was sustained virologic response 12 weeks after treatment (SVR12). For the first 14 patients, intensive pharmacokinetic sampling was done on day 10 of treatment. All patients had been infected through perinatal transmission and were treatment naïve. No patients had known cirrhosis. Ten patients (29%) weighed <17 kg. SVR12

2019 Hepatology

16. Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence

Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence CADTH Record Status (...) This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH. Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). Rapid Response. 2015 Authors' conclusions Six clinical trials demonstrated the superiority

2015 Health Technology Assessment (HTA) Database.

17. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. Full Text available with Trip Pro

Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. As the population that is infected with the hepatitis C virus (HCV) ages, the number of patients with decompensated cirrhosis is expected to increase.We conducted a phase 3, open-label study involving both previously treated and previously untreated patients infected with HCV genotypes 1 through 6 who had decompensated cirrhosis (classified as Child-Pugh-Turcotte class B). Patients were randomly assigned in a 1:1:1 (...) ratio to receive the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir once daily for 12 weeks, sofosbuvir-velpatasvir plus ribavirin for 12 weeks, or sofosbuvir-velpatasvir for 24 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy.Of the 267 patients who received treatment, 78% had HCV genotype 1, 4% genotype 2, 15% genotype 3, 3% genotype 4, and less than 1% genotype 6; no patients had genotype 5. Overall rates

2015 NEJM Controlled trial quality: uncertain

18. Real-world effectiveness and safety of ledipasvir/sofosbuvir for genotype 6 chronic hepatitis C patients in Taiwan. (Abstract)

Real-world effectiveness and safety of ledipasvir/sofosbuvir for genotype 6 chronic hepatitis C patients in Taiwan. Infection with hepatitis C virus (HCV) genotype (GT) 6 is uncommon in Taiwan, and reports of ledipasvir/sofosbuvir (LDV/SOF) treatment for GT6 are few. This study evaluates the effectiveness and safety of LDV/SOF in treating chronic hepatitis C (CHC) patients with GT6 infection.CHC patients that were infected with GT6 and treated for 12 weeks with LDV/SOF at two hospitals were

2019 Journal of gastroenterology and hepatology

19. Shortened 8-Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents with Chronic Hepatitis C Infection. (Abstract)

Shortened 8-Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents with Chronic Hepatitis C Infection. Treatment-naïve, non-cirrhotic adults with chronic hepatitis C virus (HCV) genotype 1 infection and with viremia levels < 6 million IU/mL could be effectively treated with sofosbuvir/ledipasvir for 8 weeks. The aim of this pilot, prospective, open-label, multicentre study was to evaluate the efficacy and safety of this shortened treatment course in adolescents (≥ 12 years). The efficacy (...) of the shortened 8-week treatment with sofosbuvir/ledipasvir for treatment-naïve, non-cirrhotic adolescents with chronic HCV genotype 1 infection and pre-treatment viremia level < 6 million IU/mL.

2019 Journal of Pediatric Gastroenterology and Nutrition

20. Treatment of hepatitis C in two paediatric patients using sofosbuvir during haematopoietic stem cell transplantation. (Abstract)

Treatment of hepatitis C in two paediatric patients using sofosbuvir during haematopoietic stem cell transplantation. We report the first two pediatric cases of sofosbuvir treatment during high-intensity myeloablative conditioning and engraftment phases of hematopoietic stem cell transplantation. These reports highlight the safety of sofosbuvir during all phases of transplantation and the lack of interaction between sofosbuvir and alkylating or immunosuppressive agents.

2019 Antiviral Therapy